Clinical Research Directory

Inclusion Criteria: * Body mass index (BMI) 30 to 50. * Subject Type 2 Diabetes Criteria: 1. T2DM diagnosis ≥6 months but \< 10 years 2. On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose) 3. Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., \<0.3% reduction) 4. Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit. * If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled. * Able to understand and sign informed consent document * Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions Exclusion Criteria: * Known or suspected allergy to nickel or titanium or Nitinol * Type 1 Diabetes * Use of injectable insulin * Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) * Probable insulin production failure, defined as fasting serum C Peptide \<1 ng/mL (0.3 nmol/l) * Any documented conditions for which endoscopy/colonoscopy would be contraindicated. * Contraindication to general anesthesia * Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation. * Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon. * Previous technically difficult or failed colonoscopy or endoscopy * If on metformin, history of polycystic ovarian syndrome (PCOS) * Unable or unwilling to perform home blood glucose monitoring * History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease) * Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin * Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves. * Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)